Follicular Neoplasm, Thyroid Nodule
Conditions
Keywords
Thyroid, Follicular Neoplasms, Bethesda System, Elastography, Doppler ultrasound, Thyroidectomy
Brief summary
As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing surgery will have benign lesions verified by histopathology after surgery. Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a result these subjects will have had surgery for diagnosis of a benign lesion. The aim of this study is to see whether shear-wave elastography, a new ultrasound technology can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients will not need surgery for the diagnosis of a benign lesion. The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound technology, shear-wave elastography (SWE), for the diagnosis of malignancy in follicular lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and are scheduled for thyroid surgery will be eligible to participate. All participants will undergo a detailed ultrasound examination prior to their surgery. The results of the ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy of SWE.
Interventions
DEVICEShear-Wave Elastography
Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with a Follicular Neoplasm on fine needle aspiration biopsy * Patients \>18 years of age
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) | Baseline (Day 0) | Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shear-Wave Elastography Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Shear-Wave Elastography |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 16.1 |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)
Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.
Time frame: Baseline (Day 0)
Population: All enrolled participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Shear-Wave Elastography, Benign Lesions | Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) | Transverse Plane | 17.50 kPa | Standard Deviation 7.65 |
| Shear-Wave Elastography, Benign Lesions | Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) | Sagittal Plane | 23.64 kPa | Standard Deviation 14.86 |
| Shear-Wave Elastography, Benign Lesions | Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) | Transverse Plane with Nodule in the Center | 17.89 kPa | Standard Deviation 9.1 |
| Shear-Wave Elastography, Malignant Lesions | Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) | Transverse Plane | 31.03 kPa | Standard Deviation 13.54 |
| Shear-Wave Elastography, Malignant Lesions | Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) | Sagittal Plane | 32.14 kPa | Standard Deviation 11.98 |
| Shear-Wave Elastography, Malignant Lesions | Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) | Transverse Plane with Nodule in the Center | 33.80 kPa | Standard Deviation 12.5 |